Overview

European Active Surveillance Study (EURAS)

Status:
Completed

Trial end date:
2005-12-01

Target enrollment:
0

Participant gender:
Female

Summary

EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Center for Epidemiology and Health Research, Germany

Collaborator:

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Treatments:

Contraceptive Agents
Contraceptives, Oral
Drospirenone
Levonorgestrel
Progestins

Criteria

Inclusion Criteria:

- Women starting OC use or women switching OCs

- Women willing to participate in the active surveillance for several years

Exclusion Criteria:

- Women who have contraindications for OC use